TUESDAY, Dec. 24, 2019 (HealthDay News) -- Ubrelvy (ubrogepant) tablets have been approved for acute treatment of migraine with or without aura, the U.S. Food and Drug Administration announced Monday.
Ubrelvy is the first in a class of oral calcitonin gene-related peptide receptor antagonists to receive this approval. It is not indicated for preventive treatment.
Approval was based on data from two randomized, double-blind, placebo-controlled trials involving 1,439 patients with a history of migraine with or without aura. Patients received the approved doses of Ubrelvy to treat ongoing migraine. Researchers found that compared with patients receiving placebo, a significantly greater percentage of patients receiving Ubrelvy at all doses achieved freedom from pain two hours after treatment and stopped experiencing their most bothersome migraine symptom two hours after treatment.
The most commonly reported side effects in the clinical trials were nausea, tiredness, and dry mouth. The FDA notes that Ubrelvy is contraindicated for coadministration with strong CYP3A4 inhibitors.
Approval was granted to Allergan USA.